DHHS/PHS/FDA/Office Of Facilities, Acquisition, And Central Services, Division of Contracts and Program Management, HFA-512(COB), 5600 Fishers Lane, Rockville, MD 20857

R -- CONSUMER SAFETY OFFICER SOL 157415-00-99 DUE 110398 POC Trudy Dartouzos, Contract Specialist, ph: 301/827-1765; fax: 301/827-7103 See note #1. The Food and Drug Administration [FDA], Center for Biologics and Evaluation [CBER] intends to award a purchase order for professional services, period of performance for one year, for a Consumer Safety Officer. The State of Work is: Cell and Gene Therapy. Working with product and clinical review staff in processing submissions related to molecular biology, virology and oncology that focus on cellular therapy and those utilizing reengineered genetic material. In addition, the following duties will be performed: 1] independently preparing non-standard correspondence to industry and consumers; 2] attending meetings between agency reviewers and regulated industry and prepares minutes of those meetings; 3] tracking the status of reviews in progress; notifies team of action dates; prepares ad hoc reports; 4] maintaining informatin files on products regulated by office; 5] organizing completed actions for filing in the central document control center [DCC] ; and 6] serving as liaison with DCC andresolves problems in document processing. The expertise for this position should be biologial or chemical sciences, although medical sciences are acceptable. Written quotes due by 2 pm 11/03/98. Posted 10/22/98 (W-SN264331). (0295)

Loren Data Corp. http://www.ld.com (SYN# 0078 19981026\R-0013.SOL)